Kornimate/medical-research-clean huggingface dataset:
image quality and radiation dose in angiography

Conditions: Arteriovenous Malformations; Aneurysm; Stenosis; Dural Arteriovenous Malformations

Summary: clarityiq is a novel x-ray imaging technology, that combines advanced real-time image noise reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose significantly. this is realized by anatomy-specific optimization of the full acquisition chain (grid switch, beam filtering, pulse width, spot size, detector and image processing engine) for every clinical task individually. furthermore, smaller focal spot sizes and shorter pulses are used, which are known to positively influence image quality . the final effect on the clinical image quality is investigated in this study.

the advent of interventional neuroradiology (inr) has changed the treatment of neurovascular diseases by reducing the procedural invasiveness and the recovery time needed by patients, thus improving clinical outcome. however, inr procedures often require many high-quality digital substraction angiography (dsa) runs and long total fluoroscopy times, which can result in patients being exposed to considerable radiation doses levels. in order to introduce a dose reduction technology the most important aspect is to validate the diagnostic image information. philips has developed a real-time noise reduction algorithm for dsa in neuroradiology that is capable to reduce the patient entrance dose by 75% without loss of image quality.

Eligibility criteria:
inclusion criteria: * age 18-80 * normal kidney function * neurologically intact * planned for diagnostic angiography or endovascular treatment exclusion criteria: * pregnancy * other conditions that limit the use of contrast media or ionizing radiation

Keywords: x-ray image processing neuro angiography radiation exposure
effect of colchicine on left ventricle function after anterior myocardial infarction assessed by speckle tracking

Conditions: Anterior MI; Colchicine

Summary: effect of colchicine use on left ventricles systolic function in patients with anterior s-t elevation myocardial infarction undergoing primary percutaneous coronary intervention by using speckle tracking echocardiography longitudinal strain pattern

the study participants are patients presented with anterior myocardial infarction. they will be divided into 2 groups. the first group will receive colchicine loading dose of 1mg then 0.5 mg maintenance dose in addition to the standard anti ischemic treatment for 6 months. the other group will only receive the standard anti ischmic treatment. speckle tracking echocardiography will be done to all patients to assess left ventricular longitudinal strain pattern.

Eligibility criteria:
inclusion criteria: ▪︎anterior s-t segment elevation myocardial infarction with time of presentation less than 12 hours. exclusion criteria: * severe renal impairment. * cardiac arrest. * cardiogenic shock.
a food effect study with zn-c5 in healthy post-menopausal subjects

Conditions: Healthy

Summary: this is a single-center, randomized, open-label, two-period, 2-way crossover food effect study to determine the comparative bioavailability of zn-c5 under fed and fasting conditions, following single-dose administration of zn-c5 capsules (150mg).


Eligibility criteria:
inclusion criteria: * healthy female volunteers * body mass index (bmi) between \> or = 18.0 kg/m2 and \ or = 50kg and \< or = 100kg at screening * non-smoker and must not have used any tobacco products within 2 months prior to screening, or if a smoker must be currently (and for the last 2 months prior to screening) smoking \< or = 2 cigarettes or equivalent per week. current smokers must be willing to abstain from the use of tobacco and products containing nicotine from 14 days prior to administration of study drug and through the eos visit. * no relevant dietary restrictions, and be willing to consume a high calorie, high fat breakfast and other standard meals provided during the domiciled periods of the study * post-menopausal for \> or = 24 months. status will be confirmed through testing of follicle-stimulating hormone (fsh) levels \> or = 40 iu/l at screening. participants that are post-menopausal for \< or = 24 months are still potentially eligible, but will be required to have a negative serum pregnancy test result at screening and negative urine pregnancy test result prior to study drug administration. exclusion criteria: * any condition likely to affect the participant's ability to consume the standard meal provided during the domiciled periods of the study, or any condition that may make it difficult for the patient to comply with the requirement for fasting during the study * blood donation or significant blood loss within 60 days prior to the first study drug administration * plasma donation within 7 days prior to the first study drug administration * fever (body temperature \> or = 38c) or symptomatic viral or bacterial infection or febrile illness within 2 weeks prior to screening * positive serum pregnancy test at screening or urine pregnancy test prior to administration of study drug (for participants who are post-menopausal for \< or = 24 months only) * positive toxicology screening panel or alcohol breath test * history of substance abuse or dependency or history of recreational intravenous (iv) drug use over the last 5 years (by self-declaration) * regular alcohol consumption within the 6 months prior to study drug administration, defined as \> 21 alcohol units per week

Keywords: randomized postmenopause female
using furosemide to prevent fluid overload during red blood cell transfusion in neonates

Conditions: Lung Disease

Summary: the purpose of this study is to investigate the effects of intravenous furosemide on cardio-respiratory performance in neonates receiving a packed red blood cell (prbc) transfusion who are considered at high risk of volume overload.

red cell transfusion is a very common practice in neonates, particularly in preterm infants. it has been estimated that approximately 300,000 neonates undergo transfusions annually. the decision to administer a blood transfusion to a sick anemic neonate is made after consideration of multiple clinical factors, including: poor weight gain, oxygenation failure, and recurrent apnea and bradycardia. these decisions are also influenced by physician preferences. for many years, furosemide has been used routinely by physicians during and after blood transfusions in neonates and other age groups. the rationale behind this common practice is to reduce the vascular overload that may be imposed by the additional blood volume delivered during transfusion. this belief, however, lacks the support of scientific clinical evaluation.

Eligibility criteria:
inclusion criteria: * less than 44 weeks corrected gestational age * receiving a red cell transfusion * satisfy one of the following criteria: * echocardiographic evidence of a hemodynamically significant ductus arteriosus (hsda) defined by a transductal diameter \>1.5 mm and unrestrictive systemic-pulmonary trans-ductal flow * clinical evidence of significant lung disease defined by a need for respiratory support (assisted ventilation or nasal cpap) and oxygen supplementation after 28 days of age exclusion criteria: * infants with multiple congenital anomalies or renal insufficiency * infants with hypotension, hypertension, or on any cardiac medication * infants with sepsis causing compromised clinical condition such as disseminated intravascular coagulopathy * infants with contra-indications to diuretic therapy, such as significant electrolyte imbalance, or endocrine disease

Keywords: pediatrics erythrocyte transfusion furosemide fluid overload
a study of ibrutinib with rituximab in relapsed or refractory mantle cell lymphoma

Conditions: Lymphoma, Mantle-Cell

Summary: the purpose of this study is to provide continued access to treatment for participants who continue to benefit from treatment.

mantle cell lymphoma (mcl) is an uncommon and incurable clinicopathologic subtype of b-cell non-hodgkin lymphoma (nhl). ibrutinib is a first-in-class potent, orally administered, covalently-binding small molecule inhibitor of bruton's tyrosine kinase (btki) for the treatment of b-cell malignancies and chronic graft-versus-host disease. the primary hypothesis of the study is to provide continued access to treatment for participants who continue to benefit from treatment. the study will include a screening phase (up to 30 days prior to randomization), a treatment phase (from randomization until study treatment discontinuation). safety assessments include adverse events (aes), serious adverse events (saes), clinical laboratory tests, vital signs, electrocardiogram (ecg), physical examination. the phase 2 exploratory objectives and endpoints of characterization of pharmacokinetic and pharmacodynamic of ibrutinib may continue to be evaluated using blood samples already collected. the total duration of the study will be up to 2 years 1 month.

Eligibility criteria:
inclusion criteria: * at least 1 prior treatment regimen for mantle cell lymphoma (mcl) excluding inhibitor of bruton's tyrosine kinase (btki) * documented disease progression or relapse following the last anti-mcl treatment * at least 1 measurable site of disease on cross-sectional imaging that is greater than or equal to (\>=) 2.0 centimeters (cm) in the longest diameter and measurable in 2 perpendicular dimensions per computed tomography (ct) * eastern cooperative oncology group (ecog) performance status score 0 or 1 exclusion criteria: * prior therapy with ibrutinib or other btk inhibitor * prior treatment with both lenalidomide and bortezomib. prior treatment with only 1 of these therapies is allowed * major surgery within 4 weeks of randomization * concurrent enrollment in another therapeutic investigational study * known central nervous system lymphoma * history of stroke or intracranial hemorrhage within 6 months prior to randomization
fcm analysis gr in steroid-treatment patients

Conditions: Healthy

Summary: monitoring the gr with a gr-moab and fitc-dex probes by fcm would be useful and convenient in determination gr before the steroid treatment in clinical, especially in steroid resistant states, in order to design more efficient clinical treatment protocols.

in order to assess the efficacy of this method, 100 patients with nephrotic syndrome and systemic lupus erythematosus receiving sufficient prednisolone thereafter and 50 age- and sex-matched normal controls will be studied.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of sle and ns exclusion criteria: * receiving hormone replacement therapy or had received hormone replacement therapy in three months before start of the study * received drugs or drinks containing alcohol within one month * having symptom such as infection * supersensitivity and endocrine disturbance.

Keywords: glucocorticoid-receptor flow cytometry glucocorticoid-resistant prediction
randomized comparison of warfarin dosing quality between the hamilton nomogram and a commercial computer system

Conditions: Patients at Risk for Thrombosis

Summary: randomized comparison of warfarin dosing quality between the hamilton nomogram and a commercial computer system. hypothesis: mean ttr of patients managed with the commercial computer system is non-inferior to management with the validated hamilton nomogram.

warfarin has a variable effect and many potential food and drug interactions. to have an optimal therapeutic effect the international normalized ratio (inr) needs to be maintained within the therapeutic target range. the time that a patient spends within the therapeutic target range is an intermediate quality indicator for patient outcomes and should be optimized. for this purpose, we use in our anticoagulation clinic the simple two-step hamilton nomogram, which has been validated by kim et al. who showed that the nomogram improved inr control for warfarin maintenance compared with expertise-based dosing in our anticoagulation clinic (see references). computer systems are also known to outperform expertise-based dosing, but no direct comparison of a computer system with a simple nomogram has been assessed. in this single-center randomized controlled clinical trial we will compare the simple two-step hamilton nomogram with the widely used computerized dosing management system dawn ac regarding their effect on time in therapeutic range for patients on maintenance dosing with target range 2-3.

Eligibility criteria:
inclusion criteria: * on warfarin maintenance therapy * inr target range 2-3 * at least 3 historical inrs on maintenance therapy * at least 1 historical inr in the last 3 months exclusion criteria: * participation in another study * on multiple pill strengths

Keywords: anticoagulation warfarin computer systems international normalized ratio nomograms
effects of peep on heart and lungs in obese subjects

Conditions: Obesity; Pulmonary Atelectasis; Obesity Hypoventilation Syndrome; Magnetic Resonance Imaging; Respiratory Mechanics; Electrical Impedance Tomography; Trans-Thoracic Echocardiography

Summary: aim of this study is to better understand pathophysiology of the alteration of respiratory mechanics and cardiovascular function in obese volunteer subjects. the investigators plan to test this hypothesis with a physiological, interventional study conducted on volunteers by using electrical impedance tomography in a group of patients and magnetic resonance imaging (mri) in another group.

obese subjects are prone to develop respiratory insufficiency when requiring mechanical ventilation. atelectasis is the primary responsible for respiratory insufficiency and impossibility to wean obese patients from respiratory support. the investigators do believe that the respiratory system derangements observed in the previous study during the critical illness are already present, although in lower severity, in the obese patients in their basal condition. this study will help to understand the standard cardiac and respiratory function of an obese non critically ill subject to better target the therapies during the management of the critical illness to reestablish the homeostasis of the system: the investigator's hypotheses are: * to demonstrate if morbidly obese patients show atelectasis at spontaneous breathing in the supine position and whether the increase in lung volume following peep titration is due to alveolar recruitment rather than overdistention. * to measure regional variations in ventilation/perfusion coupling at different ventilator settings * to investigate the role of diaphragm position in the development/treatment of respiratory insufficiency due to increased pleural pressure * to test if reopening of lung atelectasis through the application o a recruitment maneuver and titrated peep level would lead to an improvement in right heart function. * to assess pulmonary circulation at different levels of peep.

Eligibility criteria:
inclusion criteria: * have a photo identification document * bmi ≥ 35 kg/m2 * waist circumference \> 88 cm (for women) * waist circumference \> 102 cm (for men) exclusion criteria: * psychiatric disturbances such as anxiety, depression, schizophrenia requiring pharmacological treatment or hospitalization in the last year * subjects with any known condition, including claustrophobia or pain, which limits their ability to lie in the mr scanner for the duration of the research study * known presence of esophageal varices * recent esophageal trauma or surgery * known coagulopathy * history of pneumothorax * pregnancy * diabetes * presence of prosthesis incompatible with mr * thoracic diameter grater than 70 cm * resting heart rate (hr) \ 120 bpm and/or systolic blood pressure \ 160 mmhg and/or peripheral oxygen saturation (spo2) \< 88% * currently enrolled in another research study
the effect of dorsal genital nerve stimulation on opening urethral pressure

Conditions: Stress Urinary Incontinence

Summary: this study aims to investigate the effect of electrical stimulation of the dorsal genital nerve on the urethral pressure in healthy women.


Eligibility criteria:
inclusion criteria: * normal weight (body weight 50 kg or more, body mass index 18-5-30 kg/m2) * signed an informed consent exclusion criteria: any history of clinically significant diseases, unless regarded irrelevant and/or stable by the investigator * any history or evidence of clinically significant urinary incontinence, urinary retention, overactive bladder, or other voiding dysfunction * known or suspected nerve injuries or paraesthesia in the pelvic area * pregnancy within six months before enrolment * breastfeeding within three months before enrolment * smoking or other regular use of any form of nicotine product during the study period and the previous 3 months * current or prior participation (within 3 months before screening) in other clinical trials that might affect the results of this study (judged by the investigator) * any systemic drug use within 2 weeks before the first study day (prescription drugs, over-the-counter drugs, herbal drugs, and/or illicit drugs), except for occasional use of paracetamol (up to 4 g/day), ibuprofen, or antihistamine, hormonal contraceptives and hormone replacement therapy.

Keywords: electrical stimulation urethral pressure neuromodulation
a multi-strain probiotic reduces the frequency of diarrhea in ibs-d patients

Conditions: IBS - Irritable Bowel Syndrome; Diarrhea

Summary: the goal of this interventional clinical study is to study whether the consumption of qimeiyan probiotics in 25-35 young people with mild irritable bowel syndrome (ibs score 75 - 175) will reduce the frequency of diarrhea. 140 eligible participants (70 males and 70 females) will be enrolled in two study sites and randomly assigned to two groups of products qimeiyan probiotics and placebo. all participants will consume assigned products once a day after meals and record the critical data such as photo of feces. three site visits will be arranged and all clinical data will be captured and recorded into ctms (clinical trial management system) for statistical analysis. researchers will compare the two groups to validate if the daily consumption of qimeiyan probiotics will reduce the frequency of diarrhea in the study population.


Eligibility criteria:
inclusion criteria: * chinese males or females, age between 25-35, the ratio is 1:1; * mild irritable bowel syndrome diagnosed by ibs-sss, ibs score 75 - 175; * subjects agree not to take any other probiotics during the trial; * willing not to participate in other interventional clinical studies during the period of this trial; * fully understand the purpose, benefits obtained, possible risks and side effects of the study; * willing to comply with all research requirements and procedures; * understand the test procedure, read, and sign an appropriate informed consent form indicating their willingness to participate. exclusion criteria: * in the treatment of gastrointestinal symptoms; * lactose intolerance; * suffering from other organic diseases currently that affect the intestinal function, such as history, colon or rectal cancer resection of gastrointestinal tract, inflammatory bowel disease, diabetes, thyroid function hyperfunction or decline, congenital megacolon, scleroderma, anorexia, etc.; * controlling diet, exercising more, or taking medications to control weight or affect appetite in the last 3 months; * subjects have any of the following medical history or have been clinically examined to have the following diseases that may affect the evaluation of the test effect: obvious gastrointestinal dysfunction, liver, kidney, endocrine, blood, respiratory and cardiovascular diseases; * abuse alcohol or other drugs, supplement or otc drugs currently or in the past may cause bowel dysfunction or can affect test result evaluation; * take drugs frequently that may affect gastrointestinal function or the immune system according to pi's judgment; * use laxatives or other substances that promote digestion 2 weeks before the trial; * take dairy products or other foods containing prebiotics/bacteria 10 days before the trial.

Keywords: probiotics qimeiyan
clinical investigation for the evaluation of efficacy and safety of two products for the treatment of onychomycosis

Conditions: Onychomycosis

Summary: the efficacy and safety of enriched (x92001591) will be evaluated in a multicentric, randomized, evaluator blinded clinical investigation in 88 patients.

subjects will be treated with either the test medical device (enriched x92001591) or the reference product (loceryl, 5% amorolfine) for a period of 9 months. the primary objective of the investigation will be increase of % of healthy nail surface versus baseline, as evaluated by a blinded investigator. subjects will be followed up for a period of 9 months, with visits at d0 (baseline), d90 (month 3), d180 (month 6) and d270 (month 9).

Eligibility criteria:
inclusion criteria: * 1. patient having given freely her/his informed, written consent. 2. patient having a good general health. 3. age: between 18 and 70 years; 4. patient with superficial onychomycosis on at least one great toenail or fingernail (for at least 10% in each arm) or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement \&lt;2/3 of the tablets). 5. patient with positive koh staining. 6. patient cooperative and aware of the products modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected. 7. patient being psychologically able to understand information and to give their/his/her consent. 8. patient having stopped any systemic antifungal treatment since at least 6 months before screening and/or any topical antifungal treatment since at least 3 months before screening. 9. patient who agree to refrain from receiving pedicure/manicure, artificial nails and/or cosmetic nail varnish or other medication on the nail being treated for the entire study duration. 10. female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after study end. exclusion criteria: - 1. pregnant, breastfeeding woman or woman planning a pregnancy during the study; 2. patient considered by the investigator likely to be non-compliant with the protocol. 3. patient enrolled in another clinical trial or which exclusion period is not over. 4. patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk; 5. patient suffering from a severe or progressive disease (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, hiv, psoriasis, lichen planus, immunosuppressive pathology... 6. patient having a known allergy or hypersensitivity to one of the constituents of the tested products. 7. patient with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis...).

Keywords: onychomycosis